This Warning Letter is notification from the United States Food and Drug Administration (FDA) advising you that ROG was observed to be in violation of federal tobacco laws and regulations. Failure to correct these violations may lead to federal enforcement actions, including monetary penalties. Your response is requested in 15 working days.

On April 9, 2014, an inspector representing the FDA completed an inspection of the establishment, located at 217 Main Street, Antonio, CO 81120. During this inspection the establishment was in violation because it has a self-service display of smokeless tobacco in a facility not restricted to adults at all times.

This inspection revealed that the establishment sells, distributes, advertises, and/or promotes cigarettes, cigarette tobacco, and/or smokeless tobacco, which requires that the establishment and its owners comply with federal laws and regulations governing such practices. The violation observed during the April 9, 2014, inspection includes the following:

1. The establishment has a self-service display or an “impersonal” mode of sale that provides a consumer direct access to smokeless tobacco without restricting the facility to adults at all times. Specifically, the inspector observed of smokeless tobacco for sale from a customer accessible display on the checkout counter.

A retailer MUST sell cigarettes, cigarette tobacco, and/or smokeless tobacco only in a direct, face-to-face exchange between the retailer and the consumer and cannot use a self-service display unless a retailer ensures that minors are neither present nor permitted to enter at any time. Failure to do so violates 21 C.F.R. § 1140.16(c).

The establishment fails to ensure that minors are neither present nor permitted to enter at any time as the establishment is open to the general public during business hours. Therefore, the establishment is not restricted. It is your responsibility to ensure that no person younger than 18 years of age is present or permitted to enter the establishment at any time, or to ensure that all cigarettes, cigarette tobacco, and/or smokeless tobacco products are only sold in a direct, face-to-face exchange.

The listed violation causes your smokeless tobacco to be “misbranded” under 903 of the FD&C Act (21 U.S.C. § 387c).

You should immediately correct the violation listed above. Failure to correct the violation may result in FDA taking regulatory action without further notice. These actions may include, but are not limited to, civil money penalty, no-tobacco-sale order, seizure, and/or injunction.

The violation indicated in this letter may not be a complete list of violations at the establishment.

We will periodically inspect your establishment and review your promotional activities (e.g., website{s}) related to FDA-regulated tobacco products to assess your compliance with all applicable laws and regulations, including access, marketing, labeling, and advertising restrictions. For more information on these requirements, helpful resources for retailers, a database of inspections, and free Break the Chain of Tobacco Addiction materials, visit our website at http://www.fda.gov/TobaccoProducts. Specifically, Guidance for Industry: Compliance with Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents provides additional information on compliance with retailer responsibilities http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm252758.htm.

You have 15 working days from the date you receive this letter to respond. In your response, explain your plan for correcting the listed violation and preventing future violations. Include a telephone number and address. Note your reference number of 14CO002359 in your response and mail it to:

SP-WL Response

FDA Center for Tobacco Products

9200 Corporate Boulevard

c/o Document Control Center

Rockville, Maryland 20850

If you have any questions, contact the Center for Tobacco Products at 1-877-CTP-1373, option 1, or via email at CTP-Compliance-WL-Correspondence@fda.hhs.gov. Have your reference number ready when you call and include it with any email communications.